pomegranate extract in treating patients with rising prostate-specific antigen levels after surgery or radiation therapy for localized prostate cancer

Conditions: Prostate Cancer

Summary: rationale: pomegranate extract may keep prostate cancer from growing in patients with rising prostate-specific antigen (psa) levels after surgery or radiation therapy for localized prostate cancer. purpose: this randomized trial is studying how well pomegranate extract works in treating patients with rising psa levels after surgery or radiation therapy for localized prostate cancer.

objectives: primary * evaluate the effects of pomegranate extract in patients with and rising prostate-specific antigen (psa) levels after surgery or radiotherapy for localized prostate cancer. * determine the effect of a daily oral dose of pomegranate extract on the absolute value of psa and on the change in psa doubling time in these patients. secondary * assess toxicities associated with daily oral dosing of pomegranate extract in these patients. * determine the effect of pomegranate extract on positive psa doubling-time outcome, defined as greater than 150% baseline or a negative post-treatment psa doubling time (i.e., declining psa). outline: this is a multicenter, double-blind, placebo-controlled, randomized study. patients are stratified according to participating center. patients are randomized to 1 of 2 treatment arms. * arm i: patients receive oral pomegranate extract daily. * arm ii: patients receive oral placebo daily. treatment in both arms continues for up to 1 year in the absence of disease progression. projected accrual: a total of 180 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the prostate * must have completed prior surgery, cryotherapy, or radiotherapy for the primary tumor * documented rising prostate-specific antigen (psa) * absolute level of psa \> 0.2 ng/ml after surgery * absolute level of psa \> 1.0 ng/ml after radiation or cryotherapy * absolute level of psa ≥ 0.4 ng/ml after multiple treatment modalities (e.g., surgery with radiotherapy or radiotherapy with cryotherapy) * psa must be ≥ 100% above best nadir achieved * psa doubling time \> 3 months or ≤ 24 months * patients must have ≥ 3 rising psa time points above the minimum nadir achieved over ≥ 6 months * the interval between psa time points must be \> 2 weeks * psa ≤ 7.0 ng/ml * patients who underwent radical prostatectomy and never achieved undetectable serum psa after surgery are not eligible * gleason score ≤ 7 * no histologically positive lymph nodes * no evidence of metastatic disease by physical examination, ct scan, or bone scan patient characteristics: * life expectancy ≥ 6 months * ecog performance status 0 or 1 * no significant concomitant medical or psychiatric conditions that would limit study compliance * no known allergies to pomegranate extract * no known diabetes with hemoglobin a_1c level \> 7.0% in the past 3 months * diabetic patients entering study who have not had hemoglobin a_1c level measured in the past 3 months must have levels measured at study initiation * no clinically abnormal laboratory values \> 2 times the upper limit of normal prior concurrent therapy: * see disease characteristics * more than 4 weeks since prior and no concurrent experimental drugs, high-dose steroids, or other cancer treatment * no hormonal therapy, with the exception of neoadjuvant androgen-deprivation therapy (adt), prior to or concurrent with primary therapy * patients who received prior neoadjuvant adt must have serum testosterone ≥ 150 ng/dl * no prior or concurrent hormonal therapy for rising psa after primary therapy for prostate cancer * no finasteride or dutasteride at any time point after primary therapy and during study therapy * no other concurrent commercial pomegranate products * no other concurrent systemic or local therapy for prostate cancer * concurrent dietary/herbal supplements (e.g., saw palmetto or selenium) allowed provided dose has been stable for ≥ 2 months prior to study entry and there are no plans to change or stop the supplements during study therapy

Keywords: adenocarcinoma of the prostate recurrent prostate cancer stage i prostate cancer stage ii prostate cancer stage iii prostate cancer stage iv prostate cancer